Job Detail

Quality Compliance Specialist (9 month fixed term contract)

Inseriert am: 02.09.2020

Quality Compliance Specialist (9 month fixed term contract)


Neuchâtel, Switzerland

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  • Overview

  • Success

  • Life at Takeda

  • Opportunity

  • Responsibilities

  • Map


Overview


Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.


Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.


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Success


What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.



  • Agile

  • Ambitious

  • Analytical

  • Collaborative

  • Enthusiastic

  • Entrepreneurial


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Life at Takeda



  • A Global Top Employer

    Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.


  • At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.

    Global Manufacturing

    Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.


  • About Takeda

    At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.



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Opportunity



  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.


  • Inclusive

    Here, you will feel welcomed, respected, and valued as a vital contributor our global team.


  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.


  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.


  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.


  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.



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Quality Compliance Specialist (9 month fixed term contract)

Apply NowJob ID SR0053176Date posted 09/08/2020Location Neuchâtel, Switzerland

Takeda Neuchâtel


Site de Production Biotech | Biotech Manufacturing Site


Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.


Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.


An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced…


Quality Compliance Specialist (9-MONTH FIXED TERM CONTRACT)


About the Role:


This position is part of the Quality Compliance department for activities related to regulatory and quality compliance in the Neuchâtel site. The main objective is to contribute to the maintenance and improvement of site compliance with international GMPs and regulations, and company requirements.


Function/Specific competencies


Readiness Program:



  • Provides the KPIs linked to the adherence to the Risk Register and GMP Audits

  • In collaboration with the Quality Compliance Expert, coordinates Inspection Readiness Gap Assessments


External inspections and internal audits (Corporate)



  • Organizes the preparation of inspections

  • Coordinates the preparation of pre-required documents

  • Prepares the Inspection Preparation Plan (external inspections)

  • Prepare in collaboration with the Quality management the opening presentation for inspections where required

  • Organizes logistics (rooms, computers,…)

  • Define and enroll the inspection team in collaboration with the Quality Compliance manager and the Site Leadership Team

  • Trains the audit team on what their role in the inspection involves

  • Initiates response forms and corrective and preventive actions

  • Proposes different strategic options for the answers to observations inpectors’ concerns

  • Participates in response development, and plans for corrective and preventive actions

  • Updates all records relating to inspections in Track Wise

  • Ensures timely completion of answers to observations/concerns and of associated corrective actions

  • Proposes actions for simplification and improvement in the areas described above

  • Perform renewal and requests of GMP Certificate and Marketing Authorization provided by Swissmedic.


Management Review:



  • Prepare and analyze indicators that are related to the compliance activity

  • Propose improvement actions in case of indicators showing underperformance


General:



  • Provides Compliance Support to Partners including coaching

  • Participate in the deployment of the QMS integration

  • Participate in the continuous update of the Quality Compliance SharePoint

  • Participate in activities linked to the introduction/submission of new products

  • Prepares presentations and presents topics at the monthly Quality Council meeting

  • For all the above activities, manage and archive files (paper files and computer folder)

  • The job holder is the back-up of the Compliance Expert in activities related to the Inspection Readiness Workbook, Data Integrity and Complaints management.


Education & Experience:



  • University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent

  • At least 5 years of experience in the biotechnology and/or pharmaceutical industry, preferably both

  • Experience as an auditor for internal inspections or for GMP inspections is a plus

  • Fluent in English and French


Knowledge Skills & Abilities:



  • Good knowledge of FDA, EMA, ICH regulations and Quality system standards.

  • Experience as a Change owner or project leader.

  • Knowledgeable in inspection against regulatory / Quality standards.

  • Knowledge/Experience with Quality tools such as Trackwise.

  • Good analytical skills and ability to simplify the complex.

  • Solution oriented.

  • Good listener and communication skills.

  • Good organizational skills and continuous improvement mind.

  • Team player, reactive and flexible


Living our leadership behaviors is a basic expectation for all Takeda employees.  Takeda expects all employees to embody the following:


Leadership Behaviors



  • Be Positive

  • Be Accountable

  • Be Results Oriented

  • Be An Excellent Manager of Self and Others


Notice to Employment / Recruitment Agents:


Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.




Job ID SR0053176

Apply NowEmail Me

Back to Job Navigation (Responsibilities)


Quality Compliance Specialist (9 month fixed term contract)

Apply NowJob ID SR0053176Date posted 09/08/2020Location Neuchâtel, Switzerland

Takeda Neuchâtel


Site de Production Biotech | Biotech Manufacturing Site


Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.


Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.


An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced…


Quality Compliance Specialist (9-MONTH FIXED TERM CONTRACT)


About the Role:


This position is part of the Quality Compliance department for activities related to regulatory and quality compliance in the Neuchâtel site. The main objective is to contribute to the maintenance and improvement of site compliance with international GMPs and regulations, and company requirements.


Function/Specific competencies


Readiness Program:



  • Provides the KPIs linked to the adherence to the Risk Register and GMP Audits

  • In collaboration with the Quality Compliance Expert, coordinates Inspection Readiness Gap Assessments


External inspections and internal audits (Corporate)



  • Organizes the preparation of inspections

  • Coordinates the preparation of pre-required documents

  • Prepares the Inspection Preparation Plan (external inspections)

  • Prepare in collaboration with the Quality management the opening presentation for inspections where required

  • Organizes logistics (rooms, computers,…)

  • Define and enroll the inspection team in collaboration with the Quality Compliance manager and the Site Leadership Team

  • Trains the audit team on what their role in the inspection involves

  • Initiates response forms and corrective and preventive actions

  • Proposes different strategic options for the answers to observations inpectors’ concerns

  • Participates in response development, and plans for corrective and preventive actions

  • Updates all records relating to inspections in Track Wise

  • Ensures timely completion of answers to observations/concerns and of associated corrective actions

  • Proposes actions for simplification and improvement in the areas described above

  • Perform renewal and requests of GMP Certificate and Marketing Authorization provided by Swissmedic.


Management Review:



  • Prepare and analyze indicators that are related to the compliance activity

  • Propose improvement actions in case of indicators showing underperformance


General:



  • Provides Compliance Support to Partners including coaching

  • Participate in the deployment of the QMS integration

  • Participate in the continuous update of the Quality Compliance SharePoint

  • Participate in activities linked to the introduction/submission of new products

  • Prepares presentations and presents topics at the monthly Quality Council meeting

  • For all the above activities, manage and archive files (paper files and computer folder)

  • The job holder is the back-up of the Compliance Expert in activities related to the Inspection Readiness Workbook, Data Integrity and Complaints management.


Education & Experience:



  • University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent

  • At least 5 years of experience in the biotechnology and/or pharmaceutical industry, preferably both

  • Experience as an auditor for internal inspections or for GMP inspections is a plus

  • Fluent in English and French


Knowledge Skills & Abilities:



  • Good knowledge of FDA, EMA, ICH regulations and Quality system standards.

  • Experience as a Change owner or project leader.

  • Knowledgeable in inspection against regulatory / Quality standards.

  • Knowledge/Experience with Quality tools such as Trackwise.

  • Good analytical skills and ability to simplify the complex.

  • Solution oriented.

  • Good listener and communication skills.

  • Good organizational skills and continuous improvement mind.

  • Team player, reactive and flexible


Living our leadership behaviors is a basic expectation for all Takeda employees.  Takeda expects all employees to embody the following:


Leadership Behaviors



  • Be Positive

  • Be Accountable

  • Be Results Oriented

  • Be An Excellent Manager of Self and Others


Notice to Employment / Recruitment Agents:


Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.




Job ID SR0053176

Apply NowEmail Me